1. Field of the Invention
The present invention is a method for rapid in vivo assessment of intravenous irritation of pharmaceutical compositions.
2. Description of the Related Art
The assessment of the vascular irritability of new pharmaceutical agents, vehicles and their pharmaceutical compositions has traditionally been limited to histological characterization of postinfusion damage. These studies utilized a number of conscious animals, about 15, and required about two weeks to complete. See, Japanese Journal of Antibiotics 39(12), 3353 (1986) using the vena retroauricularis of Japanese White rabbits and An. Esp. Pediatr. 11(1), 5 (1978) using the marginal ear vein of domestic rabbits.
The method of the present invention in contrast (1) utilizes fewer animals, (2) is performed on a central vein, (3) can be completed in as short as only about 2-4 hr and (4) provides for direct contemporaneous observation of results.